• Regulatory NewsRegulatory News

    News in Focus: PDUFA VII is a step in the right direction for the rare disease community

    Craig Martin is chief executive officer of Global Genes, a nonprofit organization whose mission is to increase public awareness for rare disease and globally connect, empower and educate individuals and rare disease foundations in person, print and online. More than 400 million people worldwide are affected by 7,000+ rare diseases. In the U.S., around 1 in 10 people (more than 33 million Americans) have a rare condition. More than half of rare disease patients are chi...
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    PDUFA VII commitment letter: RWE, rare diseases see renewed attention

    The US Food and Drug Administration (FDA) on Monday released the commitment letter outlining performance goals and procedures for the upcoming reauthorization of the Prescription Drug User Fee Amendments for FYs 2023-2027 (PDUFA VII).   The agency also announced a public meeting on the reauthorization, scheduled for the afternoon of 28 September. Registration for the meeting, which will be held virtually, is free.   Many of the concepts and programs the agency di...
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    FDA FY2022 user fee table

    The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2022 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program. Each year, FDA adjusts its user fees based on factors such as inflation and the number of applications or establishments expected to pay the various fees. For FY2022, FDA’s fee for new drug applications (ND...
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    Strategic hiring and retention needs dominate PDUFA VII subgroup discussions

    Finance-oriented discussions between industry and the US Food and Drug Administration focused on strategic hiring and retention, according to the meeting summaries provided by the agency in the ongoing Prescription Drug User Fee Act (PDUFA) reauthorization negotiations of user fees from FY 2023 to 2027.   The summaries were from the finance subgroup, one of eight different groups comprised of industry and agency representatives that have been meeting over the past year...
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    Rare diseases, STAR expansion considered in PDUFA VII premarket negotiations

    Newly released minutes from meetings between industry and the US Food and Drug Administration (FDA) give observers more insight into premarket review issues in play during the negotiations for the reauthorization of the Prescription Drug User Fee Act (PDUFA VII).   FDA and industry looked at commitment language related to new molecular entity (NME) milestones and postmarketing requirements (PMR) in a 27 January meeting of the premarket negotiations subgroup. For both s...
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    PDUFA VII postmarketing talks focus on REMS, Sentinel

    As the US Food and Drug Administration (FDA) and industry worked through FDA commitments for the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA VII), a series of meetings in early 2021 defined where postmarketing priorities would lie. Risk evaluation and mitigation, best uses of the Sentinel safety system, and a pregnancy demonstration project were top of mind for both industry and FDA.   Recently released minutes from three additional meetings o...
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    PDUFA VII negotiations wind up; CMC, IT modernization issues resolved

    Negotiations between industry and the US Food and Drug Administration (FDA) for the sixth reauthorization of the prescription drug user fee program (PDUFA VII) have concluded after another round of subgroup meetings.   The most recent subgroup meetings focused on edits and updates to draft commitment language. In the 3 February FDA and industry manufacturing meeting, for example, the minutes reveal that “Both parties reviewed each draft commitment line by line and di...
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    PDUFA VII negotiations continue as industry presses for clear timelines

    As meetings continue between the US Food and Drug Administration (FDA) and industry to negotiate the upcoming reauthorization of the Prescription Drug User Fee Amendments (PDUFA VII), cell and gene therapy demands and timelines continue to loom large. Minutes from this and other end-of-year PDUFA subgroup meetings continue to show how industry and FDA are working to balance commitments and resources for PDUFA VII.   In a 17 December 2020 breakout meeting, representativ...
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    FDA's user fee reauthorization talks continue

    In ongoing negotiations, representatives from the generics drug industry continued their meetings with US Food and Drug Administration (FDA) representatives to discuss the upcoming reauthorization of the Generic Drug User Fee Amendments of 2017 (GDUFA) program. Additional rounds of meeting were held both before and after the start of the new year.   The meetings are closed to the public, and minutes are sparse on details. However, according to published minutes from ...
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    Inspections down in 2020, but CDER hit most goal dates

    During the pandemic, the US Food and Drug Administration (FDA) continued to attempt to meet goals mandated by its various user fee programs – and, generally, the agency succeeded, though a steep drop in inspections hampered some efforts.   The details of how well FDA’s Center for Drug Evaluation and Research (CDER) met its user fee commitments were laid out in a 26 January report covering the third and fourth quarters of federal fiscal year 2020 (FY20), which ended 3...
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    CBER lays out volume-staff mismatch in PDUFA VII meetings

    During an 11 December public stakeholder meeting, FDA met with representatives of patient and consumer advocacy groups as the Prescription Drug User Fee Act (PDUFA) VII reauthorization process continues.   The meeting, held virtually, began with a review of the cell and gene therapy review programs overseen by FDA’s Center for Biologics Evaluation and Research (CBER). Wilson Bryan, MD, of CBER’s Office of Tissues and Advanced Therapies (OTAT), told attendees at the vir...
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    FDA FY2021 user fee table

    The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2021 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program:   FDA User Fee Table FY2021 Prescription Drug User Fee Act (PDUFA VI) FY2021 FY2020 Change Applications:            Requiring clinical data $2,875,842 $2,942,965 -$67,123 ...